The following letter, signed by 129 public health and medical experts from 31 countries, representing every WHO region, was delivered to WHO Director General Margaret Chan earlier today. (PDF of letter)

I also submitted the letter to the FDA dockett on e-cigs; the tracking number is 1jy-8cp3-dzmg.

June 16, 2014

Dr. Margaret Chan
Director General
World Health Organization
Geneva

Dear Dr. Chan,

We, the 129 signatories to this letter, are writing to express our support for WHO’s evidence-based approach to determine the best way forward for public health to respond to Electronic Nicotine Delivery Systems (ENDS), as expressed in WHO's June 3, 2014 statement.[1]

Recently, media attention was focused on a statement by a group of “specialists in nicotine science and public health policy.”[2] Unfortunately, the statement makes several assertions about ENDS’ marketing, emissions, harms, and use that are either contradicted by available evidence or for which no evidence is currently available. (Indeed, the statement does not cite a single scientific study.)

The statement also included several policy recommendations, including effectively exempting ENDS from FCTC Articles 8 and 13 and ignoring Article 5.3.

It is fundamental that WHO and other public health authorities not buy into the tobacco industry's well-documented strategy of presenting itself as a "partner."[3] If the tobacco industry was committed to reducing the harm caused by tobacco use, it would announce target dates to stop manufacturing, marketing and selling its "more harmful" products rather than simply adding e-cigarettes to its product mix and rapidly taking over the e-cigarette market.[4]-[5] It would also immediately desist from its aggressive opposition to tobacco control policies such as tax increases, graphic health warnings and plain packaging.

By moving into the e-cigarette market, the tobacco industry is only maintaining its predatory practices and increasing profits. As stated in the guidelines for Article 5.3 of the WHO FCTC, there is a “fundamental and irreconcilable conflict of interest” between the tobacco industry’s interests and public health’s interests.”[6]

Public health embraced cigarette filters and “low tar” cigarettes as harm reduction strategies before manufacturers provided evidence and at a time when the manufacturers were well aware that these technologies did not actually reduce harm but were designed to promote cigarette sales by reassuring a concerned public that the new products were safer.[7]-[8] The negative consequences of these acts remain in cancer and heart disease hospital wards throughout the world. Ignoring the link between ENDS and the tobacco industry is overlooking the WHO FCTC Parties’ legal obligation to protect government policies against tobacco industry interference.

The aggressive marketing and promotion of e-cigarettes to youth is well-documented[9]-[10]-[11]-[12] and evidence from the US[13]-[14] and Korea[15] shows rapid growth in youth e-cigarette use, including disturbing rates among youth who have never smoked a cigarette. One e-cigarette manufacturer warns parents that “kids may be particularly vulnerable” to the flavoring in its products.[16]

Manufacturers of ENDS are making a range of false and unproven claims,[17]-[18]-[19] misleading the public into thinking these products are harmless (they are not) and effective cessation aids (unknown). Most ENDS users are "dual users" who continue to smoke cigarettes.[20] Reviews of evidence about reducing smoking (instead of quitting) show that dual users are unlikely to see any health benefit in terms of cardiovascular disease.[21]-[22] Population studies of all smokers consistently show that smokers who use ENDS are less likely to stop smoking.[23]-[24]-[25]-[26]-[27]-[28]

The evidence is insufficient to accept the assertions that ENDS are effective as a smoking cessation device. There is a single randomized controlled trial of early generation e-cigarettes that found no difference between ENDS delivered directly to experimental subjects compared with mailing subjects a voucher that they could take to a pharmacy to obtain nicotine replacement therapy.[29] One population-based cross-sectional study found that highly motivated smokers using ENDS to quit were less likely to be still smoking than smokers making unassisted quit attempts with over-the-counter NRT.[30] However, this cross-sectional study[31] showed a point prevalence of 80% of smokers using ENDS in a cessation attempt having failed, compared to 84.6% of those who tried to quit unassisted. Significantly, the former study is biased against conventional therapy (because of the additional barrier to getting the NRT) and the latter did not report a comparison with well-supervised approved cessation therapies.

There is already good evidence that ENDS emissions release several toxic substances into the environment that cause harm to health. These substances include ultrafine particles, propylene glycol, tobacco-specific nitrosamines; nicotine; volatile organic compounds (VOCs), and carcinogens and reproductive toxins, including benzene, lead, nickel, and others.[32]-[33]-[34]-[35]-[36]-[37]-[38]-[39]-[40] Proposals to allow ENDS use in indoor spaces like workplaces, bars and transportation could see significant exposure to these substances.

It is important to note that nicotine itself is not harmless, which is why strict regulatory measures are in place to control the marketing of Nicotine Replacement Therapy for smoking cessation. The 2014 U.S. Surgeon General Report includes an extensive review of acute and long-term effects of nicotine exposure. It concludes, among other things, that nicotine exposure has adverse effects on fetal growth and development, including fetal brain development.[41] The manufacturer of one electronic cigarette in the U.S. acknowledges in its product labeling that nicotine is not harmless.[42] Acute poisoning from nicotine is well established, and there has been an increase in documented cases of children being accidentally poisoned by ingesting the liquid content of ENDS cartridges.[43]

Remaining unregulated, risk profiles and potential harms these products may pose to the public are unknown. The absence of detailed evidence on adverse health effects is not evidence that no effect exists. Rather, insufficient time has elapsed to determine what effects exist and their magnitude on a population level.

Manufacturers have not secured regulatory approval for claims that ENDS are effective products for smoking cessation or harm reduction from regulatory authorities in any country. From a population perspective, it is important to know what new risks a consumer product may introduce in the market.

We applaud WHO’s commitment to listen to the experience from Member States that have successfully implemented tobacco control and regulated sales, marketing and use of ENDS. Implementation of the WHO FCTC by its 178 parties demonstrates great progress in decreasing the harm caused by tobacco use and decreasing the burden from NCDs.

There is evidence of success from many countries, including Australia, Brazil and Turkey. The former prohibits import and sales of cartridges containing nicotine, the latter two banned import, sales and marketing of e-cigarettes until, and unless, manufacturers present safety information.

Both scientific evidence and best practices are available to support a regulatory framework that will best prevent initiation of use among youth and other non-tobacco users, protect bystanders in public areas from involuntary exposure, regulate marketing, and prohibit unsubstantiated claims.

Such a regulatory framework would require manufacturers to present safety and efficacy data. In this case, the use of these products as cessation aids (if the evidence supports such use) would operate under the supervision of a health authority that could control manufacturers’ claims, impose health warnings about risks, require disclosure of ingredients and safety data and regulate product engineering as well as mandate surveillance.

This is the path that the WHO has been pursuing and encouraging. We urge you to continue doing so.Professor Özdemir Aktan
President
Turkish Medical Association

Professor John Ashton CBE
President, UK Faculty of Public Health
United Kingdom

Dr Ozen Asut
Associate Professor of Public Health
Former President of the Turkish Medical Association
Former member of Hacettepe University Medical Faculty
Editor, "Continuing Medical Education Journal" of the Turkish Medical Association
Turkey

Dileep G Bal MD MS MPH
Founder/Director of California's Tobacco Control Program (1981 to 2005)
Former American Cancer Society President (2000-2001)
Kauai District Health Officer,
Special Advisor to the Director on Tobacco and Chronic Disease,
Hawai’i State Department of Health.
Clinical Professor, Hawai’i Cancer Center and College of Medicine,
University of Hawaii
USA

Robert L Balster PhD
Butler Professor of Pharmacology and Toxicology
Research Professor of Psychology and Psychiatry
Co-Director, Center for the Study of Tobacco Products
Virginia Commonwealth University
Richmond, VA
USA

Robert Beaglehole MD
Professor Emeritus
University of Auckland
Chair, Lancet NCD Action Group
New Zealand

Jay E Berkelhamer MD FAAP
Adjunct Professor of Pediatrics, Emory University School of Medicine
Adjunct Clinical Professor of Pediatrics
Morehouse College of Medicine Past President (2006-2007)
American Academy of Pediatrics
USA

Dr Mitchel Blair
Officer for Health Promotion
Royal College of Paediatrics and Child Health
United Kingdom

Helmut Brand
Jean Monnet Professor in European Public Health
Head of the Department of International Health
President EHFG (European Health Forum Gastein)
Past President ASPHER (Association of Schools of Public Health in the European Region)
Maastricht University
The Netherlands

Peter Cooper MD
Professor and Head
Department of Paediatrics
University of the Witwatersrand & Charlotte Maxeke Johannesburg Academic Hospital
Treasurer and Member of Executive Committee, International Pediatric Association
South Africa

Thomas Eissenberg PhD
Professor of Psychology and Co-director
Center for the Study of Tobacco Products
Virginia Commonwealth University
USA

Esteve Fernández MD PhD
Head, Tobacco Control Unit, Catalan Institute of Oncology/ Bellvitge Institute of Biomedical Research - ICO-IDIBELL
Associate Professor of Epidemiology and Public Health, University of Barcelona
Spain

Valeska C Figueiredo MD PhD
Center for Studies on Tobacco and Health
National School of Public Health
Fiocruz Foundation
Brazil

Sharon Fonn MBBCh DOH DEpi FFCH PhD MASSAf
Professor
School of Public Health, University of the Witwatersrand, Johannesburg
Co-director Consortium for Advanced Research Training in Africa
Vice President Association of Schools of Public Health in Africa
South Africa

Becky Freeman PhD
Research Fellow
School of Public Health
University of Sydney
Australia

Stanton A Glantz PhD
Professor of Medicine
American Legacy Foundation Distinguished Professor of Tobacco Control
Director, Center for Tobacco Control Research and Education
Director, WHO Collaborating Centre on Tobacco Control
University of California, San Francisco
USA

Dr Gabrielle Laing
Chair
British Association for Community Child Health
United Kingdom

Harry A Lando PhD
Distinguished International Professor
University of Minnesota
USA

Professor Stephen Leeder AO
Emeritus Professor of Public Health and Community Medicine
Menzies Centre for Health Policy and School of Public Health
University of Sydney
Editor-in-Chief, Medical Journal of Australia
Australia

Simon Lenton
Co-Chair
British Association of Child and Adolescent Public Health (BACAPH)
United Kingdom

Professor Alastair H Leyland
Associate Director
MRC/CSO Social and Public Health Sciences Unit
University of Glasgow
United Kingdom

Pamela Ling MD MPH
Associate Professor of Medicine
Associate Director, Center for Tobacco Control Research and Education
University of California San Francisco
USA

Robert Loddenkemper MD FCCP
Former Chief of Department of Pneumology
Lungenklinik Heckeshorn
Berlin/Germany
Professor Emeritus of Charité University Medicine Berlin
Past-President of the European Respiratory Society
Germany

Alan D Lopez PhD
University of Melbourne Laureate Professor
Rowden-White Chair of Global Health and Burden of Disease Measurement
Director, Global Burden of Disease Group
Melbourne School of Population and Global Health
University of Melbourne
Former Chief epidemiologist, WHO’s Tobacco or Health Program (1992-1996)
Former Head, WHO Program on Substance Abuse (1996-1998)
Australia

Jose Maria Martin-Moreno MD PhD
Professor of Preventive Medicine and Public Health
University of Valencia
Spain

Bongani M Mayosi DPhil FCP(SA)
Professor and Head
Department of Medicine
Groote Schuur Hospital & University of Cape Town
Cape Town
South Africa

Wasim Maziak MD PhD
Professor and Chair, Department of Epidemiology
Robert Stempel College of Public Health and Social Work
Florida International University, Miami, Florida
Director, Syrian Center for Tobacco Studies
USA

Jim McCambridge PhD
Senior Lecturer in Behaviour Change
Faculty of Public Health & Policy
London School of Hygiene & Tropical Medicine
United KingdomProfessor Martin McKee CBE
European Centre on Health of Societies in Transition
London School of Hygiene and Tropical Medicine
United Kingdom

Robert McMillen PhD
Associate Professor
Social Science Research Center, Coordinator of the Tobacco Control Unit
Department of Psychology
American Academy of Pediatrics, Julius B. Richmond Center of Excellence
USA

John F Murray MD FRCP
Professor Emeritus of Medicine
University of California San Francisco
USA

Rima Nakkash DrPH MPH
Assistant professor
Health Promotion and Community Health Department (WHO Collaborating Center on Health Promotion and Behavioural sciences)
Coordinator of the AUB Tobacco Control Research Group
American University of Beirut
Lebanon

Thomas E Novotny MD MPH
Professor of Global Health
Graduate School of Public Health
San Diego State University
Former Assistant Surgeon General, US Public Health Service
Former US Representative to the WHO Executive Board
USA

John P Pierce PhD
Distinguished Professor in Cancer Prevention
Department of Family and Preventive Medicine
Director, Population Sciences Division
Moores Cancer Center
University of California, San Diego
USA

Professor Allyson Pollock
Prof Public Health Research and Policy
Queen Mary, University of London
United Kingdom

Dr Martina Pötschke-Langer MD MA
Head of Unit Cancer Prevention and of
WHO Collaborating Centre for Tobacco Control
German Cancer Research Center (DKFZ)
Heidelberg
Germany

Robert N Proctor PhD
Professor of the History of Science and
Professor, by courtesy, of Pulmonary and Critical Care Medicine
Stanford University
USA

[3] Peeters S, Gilmore AB. Understanding the emergence of the tobacco industry's use of the term tobacco harm reduction in order to inform public health policy. Tob Control. 2014 Jan 22. doi: 10.1136/tobaccocontrol-2013-051502.

[14] Centers for Disease Control and Prevention (CDC). Notes from the field: electronic cigarette use among middle and high school students - United States, 2011-2012.MMWR Morb Mortal Wkly Rep. 2013 Sep 6;62(35):729-30.

[41] U.S. Department of Health and Human Services. The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2014.